What is now Protopic was originally developed for organ transplant patients in an oral form called Prograf. The immune-suppressing profile of the drug proved beneficial for transplant patients, but its' positive response to skin conditions such as eczema, resulted in a new market for the manufacturer. Even so, Prograf was suspected as a cause of cancer and lymphoma in humans, even before Protopic came along.In March 2005, the U.S. Federal Drug Administration (FDA) posted a warning for doctors, health care professionals and patients about the risks associated with the use of Protopic topical cream.
Those risks are substantial. In 2004 three children and 16 adults were diagnosed with cancer linked to the use of Protopic. Two deaths were reported, and while most affected consumers were diagnosed with cancer within five months, some were identified as developing cancer within 21 days of first using the product.
Elidel is of equal concern. Approved for treatment of Resaca, eczema and Atopic Dermatitis, the ointment has been linked to the emergence of lymphoma and skin cancers in patients using the product. The FDA recently issued a public health advisory regarding the use of Elidel.
In both cases, it is believed that the suppression of the body's immune system provides a window for the onset of cancers, which include Hodgkin's and non-Hodgkin's lymphoma, squamous cell disease in children, and breast cancer in adults.
The warnings came too late for Joel Green, from Seattle Washington. He lost his wife to non-Hodgkin's lymphoma after she used Protopic to treat a serious skin rash. Green (not his real name, to protect his privacy) admits the ointment worked well on his late partner's skin condition. But they would have both been happy to live with the rash, if it meant a continued chance to live. Green's wife was hospitalized six months after first using the cream, and passed away at the age of 57. She had applied Protopic liberally, and often.
Protopic (tacrolimus) and Elidel (pimecrolimus) are known as immune system suppressors, and were approved for use only in the most serious of cases, where conventional medications had proven ineffective - and only by adults, and with children over the age of two. Ointment was to be applied only on the affected area of the skin. Contact with healthy skin was to be avoided.
While long-term safety aspects of the drugs on humans were unknown prior to approval, the FDA warned originally that tests with lab rats and other animals had yielded cancer - and the higher the dose of, in this instance, Protopic, the higher the rates of cancer emergence in test animals.
Despite such early warnings, Protopic and Elidel were heavily promoted, and reports suggest that between June 2003 and May 2004, 25 per cent of prescriptions for these drugs were written for children under two years of age.
Black box warnings were ordered by the FDA, for both drugs in January of 2006. By that time, 14 incidents of paediatric cancer had been reported, half of which involved cancer of the immune system. Infection also posed a concern. One report detailed the death of a child 18 months of age from a heart attack, after prolonged use of Protopic.
Incidence of breast cancer has also been reported. Traci Reilly of Naperville suffered a malignancy a year after using Protopic and Elidel. The lump was in the very spot where the drugs were applied.
In the last year, reports of malignancies linked to Protopic and Elidel have increased 300 per cent.
Physicians have been advised to limit use of Protopic and Elidel with their patients for short-term applications only, and to restrict its use to only those conditions, which have failed to respond to other medications. The warning against using the creams with children under two years of age still stands, and use is not recommended at all for anyone suffering from an immune system deficiency.
The makers of Protopic and Elidel, Astellas Pharma U.S. Inc. and Novartis Pharmaceuticals respectively, stand behind their products. Combined, the drugs have been prescribed to 7.5 million people over the last five years - including children.
READER COMMENTS
clogimb
on